欧州連合 - スロバキア語 - EMA (European Medicines Agency)

mylan ireland limited - lenalidomid - viacnásobný myelóm - imunosupresíva - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - imunosupresíva - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indikovaný na liečbu dospelých predtým neliečených pacientov s myelómom je mladších, ktorí nie sú spôsobilí na transplantáciu. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastické činidlá - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - antineoplastické činidlá - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - viacnásobný myelóm - antineoplastické činidlá - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

fondazione telethon ets - autológne cd34 + obohatený frakcia buniek, ktoré obsahuje cd34 + bunky transduced s antiretrovírusovej vektor, ktorý kóduje ľudský adenozín polymorfizmu (ada) cdna sekvencie z ľudskej hematopoetických kmeňových/progenitorových (cd34 +) buniek - závažná kombinovaná imunodeficiencia - immunostimulants, - strimvelis je indikovaný na liečbu pacientov s ťažké kombinované imunodeficiencie kvôli nedostatku polymorfizmu adenozín (ada-scid), pre ktorých žiaden vhodný ľudský leukocytový antigén (hla)-uzavreté súvisiace kmeňové bunky darcu je k dispozícii (pozri časť 4. 2 a oddielom 4.

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - Ďalšie lieky na nervový systém - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastické činidlá - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

欧州連合 - スロバキア語 - EMA (European Medicines Agency)

tigenix n.v. - charakterizované živé autológne chrupavkové bunky expandované ex vivo exprimujúce špecifické markerové proteíny - ochorenia chrupavky - iné lieky na poruchy muskuloskeletálneho systému - oprava jednotlivých chrupavkových defektov chrupky femorálneho kondylu kolena (medzinárodná spoločnosť na opravu chrupavky [trieda iii alebo iv)] u dospelých. sprievodnými asymptomatická chrupavky lézie (icrs triedy i alebo ii), môže byť prítomný. preukázanie účinnosti založené na randomizované kontrolované štúdie hodnotenie účinnosti chondrocelect v pacienti s léziami medzi 1 a 5 cm2.